Outcome of per protocol best-evidence based routine breast cancer care in a large regional hospital in Belgium: the importance of a prospective database in quality assurance.

AIM: Criteria for future accreditation of breast cancer centres in Belgium will be mainly based on the case load per surgeon or per centre. We would like to argue that the prospective collection of relevant data and the analysis of treatment related outcome derived from these data is feasible and should be the ultimate criterion for quality assessment and thus for accreditation since outcome is a more direct measurement of quality. METHODS: Data were prospectively collected on 715 invasive non metastatic breast cancers between 2002 and 2007 treated according to standard, best-evidence protocols in the setting of a large district hospital. Univariate and multivariate survival analysis were performed and compared to national and international databases. RESULTS: 5 year disease-free survival (DFS) and overall survival (OS) in our series were respectively 77 and 84%. In the multivariate analysis of DFS, only her-2-neu status (her-2-neu positivity being associated with a poor prognosis) and age (older age being a worse prognostic factor) were statistically significant prognostic factors. For OS, her-2-neu, age, and positive nodes were statistically significant prognostic factors. The outcome is comparable to other data sets. CONCLUSION: Centres dedicated to the care of women with breast cancer have the moral duty to produce outcome based results of their treatment. This report shows that such a collection of data is feasible and can be imposed as a prerequisite for accreditation. We also argue that outcome based data of treatment are a more solid base for quality assurance than case load.

Three-day therapy of vaginal candidiasis with clotrimazole vaginal tablets and econazole ovules: a multicenter comparative study.

The activity and tolerance of 200 mg clotrimazole vaginal tablets and 150 mg econazole vaginal ovules were compared in the treatment of vaginal candidiasis in a controlled multicenter (3 centers) study. Treatment was allocated according to a randomized list and each investigator treated 20 patients per group. Duration of therapy was 3 days. Follow-up investigations were carried out approximately 1 and 4 weeks after commencement of treatment. The results were analyzed for 54 patients treated with clotrimazole and 57 with econazole; 9 patients were excluded from the analysis because of insufficient data. At the first follow-up examination, 1 week after starting therapy, 93.7% of patients on clotrimazole and 83.7% of patients on econazole had negative cultures. The success of therapy, as judged by the clinicians, was 95.8% for clotrimazole and 88.0% for econazole. For the first and fourth week combined reviews, 86.0% of clotrimazole patients and 77.8% of econazole patients had negative cultures and the success of therapy was 88.4% for clotrimazole and 80.0% for econazole. These differences were not statistically significant but there was a clear numerical superiority for clotrimazole. Tolerance was good in all the patients and no side-effects were observed. One can conclude that the treatment of vaginal candidiasis with a 200-mg vaginal tablet of clotrimazole over 3 days is highly effective and comparable with other established treatment regimes.

Three-day therapy of vaginal candidiasis with clotrimazole vaginal tablets and econazole ovules: a multicentre comparative study.

The activity and tolerance of 200 mg clotrimazole vaginal tablets and 150 mg econazole vaginal ovules were compared in the treatment of vaginal candidiasis in a controlled multicentre (3 centres) study. Treatment was allocated according to a randomized list and each investigator treated 20 patients per group. The duration of therapy was 3 days. Follow-up investigations were carried out approximately 1 week and 4 weeks after commencement of treatment. The results were analyzed for 54 patients treated with clotrimazole and 57 with econazole: 9 patients were excluded from the analysis because of insufficient data. At the first follow-up examination, 1 week after starting therapy, 93.7% of patients on clotrimazole and 83.7% of patients on econazole had negative cultures. The success of therapy, as judged by the clinicians, was 95.8% for clotrimazole and 88.0% for econazole. For the first and fourth week combined reviews, 86.0% of clotrimazole patients and 77.8% of econazole patients had negative cultures and the success of therapy was 88.4% for clotrimazole and 80.0% for econazole. These differences were not statistically significant but there was a clear numerical superiority for clotrimazole. Tolerance was good in all the patients and no side-effects were observed.

Ultrasound assessment of puerperal uterine involution.

Echographic measurement of the early postpartum uterus was performed, mainly to investigate whether involution patterns correlate with parity, the administration of oxytocin during labor, and lactation. Our findings suggest that these factors do not have a marked effect on uterine involution.

Fetal effects of cervical ripening with extra-amniotic prostaglandin E2 in gel.

A gel containing 0.5 mg prostaglandin E2 (PGE2) was extra-amniotically instilled 90 clinically normal gravidae at term, for ripening of the cervix before elective induction of labor by amniotomy and intravenous PGE2. An acceptable increase in the Bishop score was noted to have occurred in 87/90 women, when assessed eight hours after administration of the gel; 14 of these women were then in established labor, which progressed uneventfully. Four of the 90 subjects required cesarean section for cephalopelvic disproportion. No adverse maternal or fetal effects of the procedure were detected under careful clinical, electronic and biochemical monitoring. However, epidural anesthesia adversely influenced the acid-base equilibrium of the fetus.

Induction and augmentation of labor in hypertensive patients with intravenous prostaglandin E2.

Labor was successfully induced or stimulated with intravenous Prostaglandin E2 (0.1-2.0 microgram/min) in a group of twenty-nine hypertensive gravidae at 36-41 weeks' gestation. No adverse maternal or perinatal effects of the drug were recorded.

Effectiveness of extra-ovular injection of prostaglandin E2 in tylose gel to ripen the cervix prior to elective induction of labor at term.

Ripening of the unfavorable cervix (Bishop score less than or equal to 4) was obtained in 92 clinically normal gravidae at term (68 nulliparae and 24 parous women), not in labor and with intact membranes, by injecting one or two doses (250 to 500 mug each) of prostaglandin (PG)E2 suspended in a viscous gel (5% Tylose) into the extra-ovular space. On average 7 to 8 hours after the injection the mean increase of the cervical score was 3.7 and 4.1 in the nulliparous and parous women, respectively. Complications associated with placement of the catheter were few. The method is simple, well tolerated and no untoward maternal or perinatal effects could be directly attributed to it. However, suitable criteria for predicting both the effect of the procedure and the optimal PG dose to be administered are still needed.

A comparison of buccal (oromucosal) and oral prostaglandin E2 for the elective induction of labor.

In 100 clinically-normal women, labor was induced at term by low amniotomy and PGE2. The drug was administered by either the oral or the oromucosal route, the same incremental dose scheme (initial dose of 0.5 mg; hourly increment of 0.5 mg until adequate uterine stimulation or a maximum single dose of 3.0 mg) being applied. Both routes of administration had comparable efficacy and were equally safe. The incidence of abnormal monitoring findings (uterine hypertonus, transient bradycardia and dips II during the first stage; late decelerations, progressive and transient bradycardia during the second stage of labor) and of low Apgar scores were similar. Acid-base and lactate-pyruvate equilibria in mother and fetus were not influenced by the route of drug administration in parous women. In nulliparae treated with PGE2 by the oromucosal route, higher values were found for the fetal-maternal difference in excess lactate than in those given oral PGE2; however, this is probably of little clinical importance.